TMT Fusion Plate vs. Two Crossed Screws

AO Clinical Investigation and Publishing Documentation

Status

Terminated

Conditions

Clinical Indication for First Metatarsal Joint Arthrodesis

Treatments

Procedure: TMT Fusion plate

Procedure: Two crossed screws

Study type

Interventional

Funder types

Other

Identifiers

NCT02096146

TMT Fusion Plate

Details and patient eligibility

About

This study will compare TMT Fusion Plate versus two crossed screws for the fixation of first tarsometatarsal joint arthrodesis. Patients who meet eligibility criteria will be randomly assigned to one of these two treatment options.

Full description

Tarsometatarsal joint arthrodesis is a common procedure which can be performed using various devices such as screws, plates or both. The Tarsometatarsal Fusion Plate from "DePuySynthes" is a new device designed to encourage bony fusion of the 1st TMT joint, and is expected to lead to earlier fusion compared to the current standard of care of using 2 crossed screws. This is expected, in turn, to result in an earlier reduction in pain and an earlier return to full activity. At this time there is insufficient data directly comparing outcome following surgery for patients treated with screws or plates, and a study protocol which produces a higher level of evidence is therefore necessary.

The main aim of this study is to compare patient-reported outcome following surgery for patients undergoing joint arthrodesis using the TMT Fusion plate versus screws only. It is expected that surgery will improve patient-reported outcome similarly for both treatment groups in the long-term, but that the improvement will occur earlier for the plate group. For this study patient-reported outcome will be assessed by the walking/standing and pain domain scores of the Manchester Oxford Foot Questionnaire (MOXFQ). An earlier improvement in any of these two domains would be considered to be valuable. The primary analysis will therefore compare the time to a minimal clinically relevant improvement for any of the two MOXFQ domains for patients treated with TMT fusion plate versus patients treated with only screws during the first 12 months following surgery.

An economic evaluation from a societal perspective will determine the incremental cost-effectiveness of the TMT fusion plate versus the 2 crossed screws technique for 1st TMT joint fusion. Therefore a randomized controlled trial will be conducted, where patient-reported outcomes as well as clinical outcome parameters will be assessed.

Enrollment

12 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age: between 18 and 65 years
At least one of the following:
- 1st TMT arthritis
- hallux valgus (intermetatarsal angle (IM) 1-2 angle > 15° on plain x-ray)
- 1st ray hypermobility with or without flat foot
Painful condition
Ability to understand the content of the patient information / Informed Consent Form
Willingness and ability to participate in the clinical investigation according to the Clinical Investigation Plan (CIP)
Signed and dated IRB/EC-approved written informed consent

Exclusion criteria

Active infection
Previous surgery on the 1st ray of the same foot
Previous non-union on the 1st ray of the same foot
Clinical obvious arthritis in other joints of the lower extremities
Purely seeking plastic surgery
Peripheral vascular disease (e.g. advanced diabetes)
Peripheral sensory neuropathy (e.g. advanced diabetes)
Concurrent surgery of the contralateral foot
Any previously medically unmanaged severe systemic disease
Substance abuse that would preclude reliable assessment
Prisoner
Participation in any other medical device or medicinal product study within the previous month that could influence the results of the present study